Pediatric Obesity Clinical Trial
| NCT number | NCT02833051 |
| Other study ID # | EnergyBalance01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2015 |
| Est. completion date | November 2015 |
| Verified date | January 2021 |
| Source | Penn State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this project is to examine the effects of an acute bout of exercise on children's energy intake over the course of a day. Previous studies in adolescents and adults have shown exercise to be effective in decreasing short-term energy intake, with some variability. Individual characteristics such as habitual physical activity and psychological factors may influence the effect of exercise on energy intake, but these factors have yet to be examined. The investigators have assembled a multi-disciplinary team of researchers, with expertise in eating behavior, exercise, psychology, and clinical research in order to examine these questions. First, the investigators will examine the difference in energy intake at lunch, snack, and dinner meals in response to 30 minutes of imposed exercise compared to 30 minutes of rest. Second, the investigators will collect objective measures of children's habitual physical activity, child characteristics (body composition, eating behavior traits), and individual responses to the controlled exercise bout. The investigators can then examine both group and individual differences in the energy intake response to exercise. Children (ages 9-12) will be tested over the course of three visits. The key outcome will be differences in energy intake in response to exercise vs. rest. Secondary outcomes include the influence of differences in habitual physical activity, personal characteristics, and responses to the exercise bout on children's energy intake. The long term goal of this line of research is to understand the mechanisms behind the interaction between exercise and energy intake. The translational potential of this research will be to inform personalized childhood obesity prevention strategies in children at risk for overweight.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 9 Years to 12 Years |
| Eligibility | Inclusion Criteria: - English as a native language - Reading at/above grade level - Generally healthy - Child is "normal weight" below the 85% age- and sex-specific BMI percentile - Child has at least one biological parent classified as "overweight" or "obese" (= 25 kg/m^2) - Regularly eats breakfast Exclusion Criteria: - Contraindications to exercise testing (as defined by the American College of Sports Medicine) - Medical conditions - Psychiatric conditions - Participation in competitive sports teams (year-round or more than 3 practices / week) - Food allergies or other dietary restrictions |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Pennsylvania State University | University Park | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Penn State University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Liking of foods | Ratings of how much child likes specific foods used in the study test meals, completed on visual analog scales | Collected at week 1 and 2 of the study | |
| Other | Wanting of foods | Ratings of how much child wants to eat specific foods used in the study test meals, completed on visual analog scales | Collected at week 1 and 2 of the study | |
| Other | Fullness feelings | Ratings of how full the child feels on a child friendly visual analog scale | Collected at multiple time points during weeks 1, 2, and 3 | |
| Other | Height | Height in cm measured by stadiometer | Collected at week 1 | |
| Other | Weight | Weight in kg by standard digital scale | Collected at week 1 | |
| Other | Body fat percentage | Assessed by bioelectrical impedance analysis scale | Collected at week 1 | |
| Other | Body mass index | Calculated from height and weight (kg/m^2) | Collected at week 1 | |
| Other | BMI percentile | Calculated from height, weight, age, sex | Collected at week 1 | |
| Other | BMI z-score | Calculated from height, weight, age, sex | Collected at week 1 | |
| Other | Fat mass index | Calculated from body fat percentage, weight, height | Collected at week 1 | |
| Other | Fat-free mass index | Calculated from fat mass, weight, height | Collected at week 1 | |
| Other | Appetitive traits | Parent-reported questionnaire of habitual eating styles in children | Collected at week 1 | |
| Other | Pubertal development | Parent-reported questionnaire | Collected at week 1 | |
| Other | Family demographics | Parent-reported questionnaire | Collected at week 1 | |
| Primary | Baseline energy intake | Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information. | Collected at week 1 of the study | |
| Primary | Energy intake following exercise | Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information. | Collected at week 2 or 3 (randomized) of the study | |
| Primary | Energy intake following sedentary control | Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information. | Collected at week 2 or 3 (randomized) of the study | |
| Primary | Activity-related energy expenditure - Baseline day | Measured using ActiGraph accelerometers | Collected in the laboratory at week 1, 2, and 3, and at home for one week between the 2nd and 3rd laboratory visits | |
| Primary | Activity-related energy expenditure - Exercise day | Measured using ActiGraph accelerometers | Collected at week 2 or 3 (randomized) of the study | |
| Primary | Activity-related energy expenditure - Sedentary control day | Measured using ActiGraph accelerometers | Collected at week 2 or 3 (randomized) of the study | |
| Secondary | Baseline submaximal fitness test performance | YMCA submaximal cycle ergometer test - American College of Sports Medicine | Collected at week 1 of the study | |
| Secondary | Exercise test performance (70% intensity) - Heart rate | Measured by Polar Heart Rate Monitor | Collected at week 2 or 3 (randomized) of the study | |
| Secondary | Exercise test performance (70% intensity) - Blood pressure | Measured by registered nurse or trained research assistant | Collected at week 2 or 3 (randomized) of the study | |
| Secondary | Exercise test performance (70% intensity) - Ratings of perceived exertion | Measured on the Borg Scale | Collected at week 2 or 3 (randomized) of the study | |
| Secondary | Exercise test performance (70% intensity) - Completion | Children's completion of the full 30 minutes of 70% intensity exercise | Collected at week 2 or 3 (randomized) of the study | |
| Secondary | Child sleep patterns | Measured using ActiGraph accelerometers | Collected at home for one week between the 2nd and 3rd laboratory visits | |
| Secondary | Child physical activity patterns | Measured using ActiGraph accelerometers | Collected at home for one week between the 2nd and 3rd laboratory visits |
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